A 8 Weeks Study to Evaluate Efficacy & Safety of rhNGF vs Vehicle in Patients After Cataract and … (NCT03035864) | Clinical Trial Compass
CompletedPhase 2
A 8 Weeks Study to Evaluate Efficacy & Safety of rhNGF vs Vehicle in Patients After Cataract and Refractive Surgery
Italy180 participantsStarted 2017-01-12
Plain-language summary
The primary objective of this exploratory study is to assess preliminary efficacy and safety of rhNGF when administered as eye drops to patients after cataract and refractive surgery.
The main criteria for evaluation were:
* Change from baseline in SANDE scores for severity and frequency assessed at 8 weeks of treatment (primary efficacy endpoint)
* Changes in Cornea vital staining with fluorescein (National Eye Institute \[NEI\] scales) assessed at 8 weeks of treatment (co-primary efficacy endpoint)
* Changes in conjunctiva vital staining with fluorescein (NEI scales) (secondary efficacy endpoint);
* Changes in Tear Film Break-Up Time (TFBUT)(secondary efficacy endpoint);
* Changes in Cochet-Bonnet corneal aesthesiometry (secondary efficacy endpoint);
* Changes in Nerve count and morphology at scanning laser in vivo corneal confocal microscopy (only patients who had Laser-Assisted In situ Keratomileusis \[LASIK\] surgery) (secondary efficacy endpoint);
* Changes in SANDE scores (face values) for severity and frequency (secondary efficacy endpoint);
* Incidence and frequency of treatment-emergent adverse events (TEAEs), assessed throughout the study (safety endpoint).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female ≥18 years old
✓. Patients who are characterized by the following clinical features:
✓. History of cataract or refractive corneal surgery in the study eye(s) in the previous 6 months;
✓. Mean Symptom Assessment in Dry Eye (SANDE) score for severity and frequency of at least 30 at baseline
✓. The same eye (study eye) must fulfill all the above criteria
✓. Best corrected distance visual acuity (BCDVA) score of ≥ 0.1 decimal units in both eyes at the time of study enrolment
✓. Female patients must have negative pregnancy urine test if at childbirth potential.
✓. Only patients who satisfy all requirements for informed consent may be included in the study. Written Informed Consent must be obtained before the initiation of any study-specific procedures.
Exclusion criteria
✕. Any ocular disease other than Dry Eye requiring treatment with topical medications in either eye at the time of study enrolment.
What they're measuring
1
Change From Baseline in SANDE Scores for Frequency and Severity Assessed at 8 Weeks of Treatment.
Timeframe: Baseline and Week 8
2
Changes in Cornea Vital Staining With Fluorescein (National Eye Institute [NEI] Scales)
✕. Any active ocular infection or active inflammation in either eye unrelated to Dry Eye.
✕. Presence or history of any systemic or ocular disorder, condition or disease (with particular attention to malignancies and neuro-oncological diseases) that could possibly interfere with the conduct of the required study procedures or the interpretation of the study results.
✕. Use of therapeutic or Refractive Contact lenses in either eye at the time of study enrolment;
✕. History of ocular surgery in the study eye(s), excluding corneal refractive or cataract procedures, within 90 days of study enrolment.
✕. Females of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) are excluded from participation in the study if they meet any one of the following conditions:
✕. are currently pregnant or,
✕. have a positive result at the urine pregnancy test (Baseline/Day 0) or,